FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CUSA Clarity Ultrasonic Surgical Aspirator System
K Number: K221763
·
Decision Jul 15, 2022
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
155
Applicant Total
13
Review Days
28
Basic Information
- Device Name
- CUSA Clarity Ultrasonic Surgical Aspirator System
- K Number
- K221763
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra LifeSciences Corporation
- Date Received
- June 17, 2022
- Decision Date
- July 15, 2022
- Product Code
- LFL
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFL), ordered by most recent decision date.
SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)
FDA 510(k)
FDA Unclassified
·Unknown
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
FDA 510(k)
FDA Unclassified
·Unknown
Tenex 2nd Generation System
FDA 510(k)
FDA Unclassified
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CUSA® Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
·Unknown
Ultrasonic Surgical System
FDA 510(k)
FDA Unclassified
·Unknown
CUSA Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Integra LifeSciences Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | Apr 9, 2025 | Substantially Equivalent |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Jul 11, 2024 | Substantially Equivalent |
| K210128 | INTEGRA Wound Matrix (Macro-Channels) | Oct 8, 2021 | Substantially Equivalent |
| K193346 | Codman Surgical Patties & Strips | Nov 20, 2020 | Substantially Equivalent |
| K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | Jun 23, 2020 | Substantially Equivalent |
| K190588 | Integra TITAN Reverse Shoulder System | Dec 2, 2019 | Substantially Equivalent |
| K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System | Apr 1, 2019 | Substantially Equivalent |
| K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | Dec 7, 2018 | Substantially Equivalent |
| K182801 | Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable | Nov 27, 2018 | Substantially Equivalent |
| K173717 | Integra TITAN Reverse Shoulder System | Jun 21, 2018 | Substantially Equivalent |